MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-62-user had poor technique.Test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(6) 2018, in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for erratic and low blood glucose test results (accompanied by symptoms).The customer is concerned with tests results from results obtained of 59 and 97mg/dl.The expected fasting blood glucose test result range is 120-130mg/dl.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call on (b)(6) 2018, a blood test was performed non-fasting by the customer and produced test results of 129 and 134mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 05/31/2020, and open vial date is one month ago.The meter memory was reviewed for previous test result history: (b)(6).Customer concern with the results the meter is giving.Customer states that she run a back-to-back blood test and 59/97mg/dl fasting and the test were done on the same finger.Customer states that she was feeling symptoms of low blood sugar with the results of 59/97.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4) returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Note: manufacturer contacted customer on 12/21/2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for erratic and low blood glucose test results (accompanied by symptoms).The customer is concerned with tests results from results obtained of 59 and 97mg/dl.The expected fasting blood glucose test result range is 120-130mg/dl.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call on 12/12/2018, a blood test was performed non-fasting by the customer and produced test results of 129 and 134mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 05/31/2020 and open vial date is one month ago.The meter memory was reviewed for previous test result history: result 1:109mg/dl, date:12/2012, time:4:09pm fasting; result 2:108mg/dl, date:12/2012, time:121pm fasting; result 3:150mg/dl, date:12/2012, time:3:35am non- fasting; result 4:159mg/dl, date:12/2012, time:143am non- fasting; result 5:97mg/dl, date:12/2012, time:12:24am fasting; result 6 59mg/dl, date:12/2012, time:12:22am fasting.Customer concern with the results the meter is giving.Customer states that she run a back to back blood test and 59/97mg/dl fasting and the test were done on the same finger.Customer states that she was feeling symptoms of low blood sugar with the results of 59/97.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8212446
• Report Number: 1000113657-2019-00009
• Device Sequence Number: 19362624
• Product Code: NBW
• UDI-Device Identifier: 00021292006068
• UDI-Public: (01)00021292006068
• Combination Product (Y/N): N
• Initial Reporter State: AL
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV3041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY